degree in life science related field, - Minimum of 3 years of experience in the medical affairs in the pharmaceutical industry, - Experience and knowledge in the pharmaceutical industry, preferably in Regulatory Affairs (CMC) - Excellent communication and writing skills in French and English ...
science related field, - Minimum of 3 years of experience in the medical affairs in the pharmaceutical industry, - Experience and knowledge in the pharmaceutical industry, preferably in Regulatory Affairs (CMC) - Excellent communication and writing skills in French and English - Experience in leading
Updating of Regulatory requirements - Pre market Regulatory activities - Post market Regulatory activities - Spokesperson for Notified Bodies - Advising Business Manager on RA topics - Formulate and implement RA policy - Responsible for DMF REQUIREMENTS - Bachelor
main focus of this job is to maintain the life cycle management of OTC pharma products. In addition the manager is also involved in the development and registration of new products. RESPONSIBILITIES Manager you are responsible and involved in: - LCM of OTC pharma - Newly
Sciences as Regulatory professional including managerial experience • Strong product and governmental knowledge and network • Strong writing and speaking skills in English • Hands-on mentality to anticipate to the daily operations • A natural leader with strong ambition and self-discipline
teams in Development, Sales & marketing and Management with regards to regulatory requirements - (re)write and maintain SOP's - Collaborate with Market Access, Drug Safety, Supply Chain Management, Clinical Development, Quality Management REQUIREMENTS - University degree
Sales en Marketing Manager - beantwoorden van vragen van afnemers en ondersteuning bieden bij de registratie - behartigen van de belangen van het bedrijf in externe organisaties - actief meeschrijven aan relevante product normen en het kwaliteit management systeem RESPONSIBILITIES
DESCRIPTION You will be responsible for writing scientific documents and regulatory reports (MADs, IMPDs, Variations, etc.). You ensure full compliance with regulatory requirements. You are reporting to the Regulatory Affairs CMC Manager. RESPONSIBILITIES
processes are established and adhere to. REQUIREMENTS - University degree in medicine, pharmacy, life sciences or chemistry - Minimum of 8 years relevant experience in regulatory affairs within the pharmaceutical industry - experience in global regulatory affairs encompassing
COMPANY Our client is a professional Pharmaceutical organization, based in Netherlands. This international pharmaceutical company is located in Zuid-Holland and is looking for a Junior Regulatory Affairs Contractor. ROLE
Assamble regulatory documents in eCTD/NEES - Act as a secretary tasks for RA Director - Be responsible for coordinating and respond to regulatory/administrative questions from customers - Archiving and tacking activities REQUIREMENTS - MBO/HBO educational level - Previous
product registration approvals by ensuring compliance with regulatory requirements - Contribute with regulatory submissions and prepare registration dossiers - Act as a regulatory liaison with the R&D and marketing department for the development of regulatory plans - Implementation of the regulatory
Experience with regulatory aspects of CHC drug development, registration and product maintenance - Experience with handling MRPs and DCPs - Excellent understanding of regulatory practices - Good communication and writing skills in Dutch and English - Ability to think strategically - Experience with leading
required regulatory compliance databases, systems and processes - Proactively manage the impact of regulatory changes - Provide input to regulatory strategies and process improvement REQUIREMENTS - A minimum of 3 years of experience in a pharmaceutical environment ...